FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OptikView GUP2103CMI
K Number: K191705
·
Decision Mar 16, 2020
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
134
Applicant Total
2
Review Days
264
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Basic Information
- Device Name
- OptikView GUP2103CMI
- K Number
- K191705
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Linden Group Corp
- Date Received
- June 26, 2019
- Decision Date
- March 16, 2020
- Product Code
- PGY
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PGY | Display, Diagnostic Radiology | FDA class 2 | Radiology |
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Other Clearances by The Linden Group Corp
| K Number | Device Name | ||
|---|---|---|---|
| K160328 | DIVA ZSP2105CMI with QUBYX PerfectLum bundle | Feb 25, 2016 | Substantially Equivalent |